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3M Sterile U Web Meeting January 20, 2011 Welcome! Thank you for attending today s meeting, it will begin shortly. How do I get a CE Certificate? Next week, all of today s meeting participants will be sent an email containing instructions for obtaining a CE Certificate for today s meeting. The email will be sent to the email address you provided when you logged-in to today s meeting. If there are others listening with you today who did not log-on, you may forward the CE certificate email to them. Welcome! Title: It s Not Just a Numbers Game: Appropriate Use of Chemical Indicators Facilitators: Sandra Velte, 3M Technical Service Beth Fritcher, 3M Sterilization Assurance Speaker: Martha Young, MS, BS, CSPDT Housekeeping Questions Mute feature (*7 = unmute; *6 = mute) Chat feature Technical difficulties CE Credits Post session follow-up Disclosure Statement Martha Young, MS, BS, CSPDT Martha L. Young, LLC Retired from 3M Consultant for 3M 3M stock holder marthalyoung1@aol.com For more information: www.3m.com/atteststerileuonline 3 4 Objectives 1. Discuss the critical variables, endpoint, and stated values that relate to chemical indicator performance. 2. Discuss the 6 classes of chemical indicators. 3. Discuss the Association for the Advancement of Medical Instrumentation (AAMI) and the Association of perioperative Registered Nurses (AORN) recommended practices for use of these chemical indicators. 4. Discuss how to do a recall based on the results of a chemical indicator. Evidence-Based Guidelines Associations for the Advancement of Medical Instrumentation. Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79:2010 & A1:2010 (Consolidated Text) Can now order through AORN and maybe IAHCSMM at AAMI membership prices. On the bottom of slides are the reference and location of the information. 5 6 1

Chemical Indicator Performance Standard for Manufacturers Sterilization of health care products-chemical indicators-part 1: general requirements. ANSI/AAMI/ISO 11140-1:2005/(R)2010 Specifies performance requirements and/or test methods for chemical indicators intended for use with sterilization processes employing steam, dry heat, ethylene oxide, γ or β radiation, steamformaldehyde or vaporized hydrogen peroxide. Intended for manufacturers of chemical indicators and specifies the general requirements for chemical indicators. Specifies information that manufacturer needs to provide for the end user in the instructions for use. Key Definitions Critical Variables Parameters identified as being essential to the sterilization process (and require monitoring) For example, the critical variables for steam sterilization to be effective Time Temperature Steam 7 8 ANSI/AAMI/ISO 11140-1:2005/(R)2010 (Mfrs. Standard) Key Definitions Critical variables are variables that are critical for a sterilization process to be effective Steam Ethylene Oxide Time Temperature Water 1 Relative Humidity EO Concentra -tion Plasma Hydrogen Peroxide Key Definitions End Point point of the observed change as defined by the manufacturer occurring after the indicator has been exposed to specified stated values Migration Color change 9 Vaporized Hydrogen Peroxide ANSI/AAMI/ISO 11140-1:2005/(R)2010 (Mfrs. Standard) 1 as delivered by saturated steam 2 if applicable 2 10 ANSI/AAMI/ISO 11140-1:2005 /(R)2010 (Mfrs. Standard) Key Definitions Stated Values value or values of a critical variable at which the indicator is designed to reach its endpoint as defined by the manufacturer Key Definitions Stated values on packaging or product Example: 3 Stated Values for a Specific Lot Temperature with corresponding times to reach endpoint in presence of saturated steam in a resistometer under ideal steam sterilization conditions Lot 2012-09 JT 121 C 128 C 135 C 22.1 5.7 2.1 Class 5 Integrating Indicator Class 6 Emulating Indicator 11 ANSI/AAMI/ISO 11140-1:2005 /(R)2010 (Mfrs. Standard) 12 ANSI/AAMI/ISO 11140-1:2005 /(R)2010 (Mfrs. Standard) 2

Key Definitions Stated Value Testing Results vs Hospital Results 13 Resistometer Specialized test vessel capable of reproducible cycles and used by manufacturers to characterize the performance of chemical indicators Come-Up Time Time it takes for the sterilizer to get to the selected exposure temperature ANSI/AAMI/ISO 11140-1:2005 /(R)2010 (Mfrs. Standard) Think of it like the pre-heat time on your oven Temperature F 14 Resistometer Test Vessel 270 250 Come-up-time (less than 10 sec.) One Vacuum Pulse Time Temperature F 250-270- Hospital Sterilizer Come-up-time (5-10 minutes) Time Class 1 Process Indicators Class 2 Indicators for use in Specific Tests Class 3 Single Variable Indicators Class 4 Multi-variable Indicators Class 5 Integrating Indicators Class 6 Emulating Indicators 15 ANSI/AAMI/ISO 11140-1:2005 /(R)2010 (Mfrs. Standard) ANSI/AAMI ST79:2010 Section 10.5.2.1 ANSI/AAMI/ISO 11140-1:2005 /(R)2010 (Mfrs. Standard) 16 ANSI/AAMI ST79 :2010 Section 10.5.2.1 Class 1: Process Indicators Use with individual units to indicate that the unit has been directly exposed to the sterilization process Exposure Control/External CIs Distinguish between processed and unprocessed units Designed to react to one or more of the critical process variables 17 Class 2: Indicators for Specific Tests Equipment Control Testing sterilizer performance Bowie-Dick Test monitors efficacy of air removal and steam penetration in 270-275 F (132-135 C) dynamic-air removal sterilizers (i.e., vacuumassisted sterilizers) ANSI/AAMI ST79 :2010 Section 10.5.2.1,10.7.6 18 Class 2: Indicators for Specific Tests Bowie-Dick tests can detect: Air leaks Inadequate air removal Inadequate steam penetration Presence of non-condensable gases: air or gases from boiler additives Used for routine daily testing and qualification testing ANSI/AAMI ST79:2010 Section 10.7.6 3

Bowie-Dick Test Bowie-Dick Test Uniform color change Use If not uniform, shut down and call repair person Re-qualify if major repair 19 ANSI/AAMI ST79:2010 Section 10.7.6 20 Class 3: Single Variable Indicators (Internal CIs) Designed to react to one of the critical variables Indicates exposure to a sterilization process at a stated value (SV) of the chosen variable Do not provide as much information as Class 4, 5 or 6 Class 4: Multi-variable Indicators (Internal CIs) Designed to react to two or more of the critical variables Indicates exposure to a sterilization cycle at stated values of the chosen variables 21 ANSI/AAMI ST79 :2010 Section 10.5.2.1 22 ANSI/AAMI ST79:2010 Section 10.5.2.1 Class 5: Integrating Indicators (Internal CIs, Load Control) Designed to react to all critical variables Stated values equivalent to the performance requirements for BIs (ISO 11138 series: 2006) Class 5: Integrating Indicators (Internal CIs, Load Control) Response must correlate to a BI at three time/temperature relationships 250 F/121 C 275 F/135 C and at one or more temperatures in between Stated value at 250 F/121 C must be >16.5 min Pass dry heat test/not reach end point in 30 min at 280 F/137 C 23 ANSI/AAMI ST79:2010 Section 10.5.2.1 24 ANSI/AAMI/ISO 11140-1:2005 /(R)2010 (Mfrs. Standard) 4

Class 6 Emulating Indicators (Internal CIs, Load Control) Designed to react to all critical variables Stated value generated from the critical variables of the specific sterilization process. Cycle verification indicators Class 6 Emulating Indicators (Internal CIs, Load Control) Pass dry heat test/not reach end point in 30 min at 280 F/137 C Response does not correlate to a BI Does not require three stated values Does not require a stated value at 250 F/121 C, >16.5 minutes 25 AAMI ST79:2010 Section 10.5.2.1 26 ANSI/AAMI/ISO 11140-1:2005 /(R)2010 (Mfrs. Standard) Test Data Class 5 vs. Class 6 Indicators Disinfection, Sterilization, and Antisepsis 2010 Edition Proceedings of the Conference on Disinfection, Sterilization, and Antisepsis; Principles, Practices, Current Issues, New research, and New Technologies. Ft. Lauderdale, June 6, 2009 APIC; William Rutala, Editor 27 ANSI/AAMI/ISO 11140-1:2005 /(R)2010 (Mfrs. Standard) 28 3M 2010. All Rights Reserved. 29 Study Objective: Compare response of Class 5 Integrating Indicators, Class 6 Emulating Indicators, and biological indicators at various steam sterilization exposure conditions. Basic objective Verify the Class 6 capability as a cycle verification indicator. Study Design Test Devices 3 Lots of Class 5 indicators (250ºF SVs 19.3-20.2 minutes; 262ºF SVs 5.1-5.5 minutes; 270ºF SVs 1.8 2.0 minutes) 3 Lots of Class 6 indicators ( A SV 4 minutes @ 270ºF) 3 Lots of Class 6 indicators ( B SV 3.5 minutes @ 273ºF) 3 Lots of biological indicator strips ( A D-value 1.9 2.5 minutes) 3 Lots of biological indicator strips ( B D-value 1.5 2.3 minutes) Test Protocol 1. Expose indicators to sterilization processes at 240ºF (115ºC); 250ºF (121ºC); 270ºF (132ºC) 2. Include exposure times for fail and pass cycles 3. Compare ability of different indicators to detect failure 30 conditions 5

Results - 240ºF Testing Results - 250ºF Testing 31 32 Results - 270ºF Testing Study Conclusions The Class 6 CIs evaluated in this study performed in accordance with their stated values when tested in a steam resistometer at 270ºF but also showed significant color change when exposed in the 240ºF and 250ºF cycles. In contrast, the Class 5 CI and both of the BIs tested showed a greater percentage of failure results at the 240ºF and 250ºF temperatures, indicating more minimal response to the lower temperatures that would occur during cycle conditioning. The data from these studies raise some questions regarding the capability of Class 6 CIs to detect potential failure conditions in healthcare facility steam sterilization cycles. 33 34 Class 6 Emulating Indicators May be used as an internal CI. May be used in a PCD to release nonimplantable loads A Class 6 emulating indicator within a PCD may be used as part of the release criteria for loads containing implants (see Section 10.6.3) All loads containing implants should contain a BI. It should be noted that Class 6 emulating indicators are cyclespecific; that is, they should be used only in the specific cycles for which they are labeled. 35 ANSI/AAMI ST79 :2010 Table 7, Section 10.5.2.1, 10.5.2.2.2 Class 6 Emulating Indicators Likewise, although Class 6 emulating indicators (a different technology than Class 5 integrating indicators) are designed to react to all critical variables of specified sterilization cycles, they do not directly measure the lethality of a certain cycle and they are not intended to be used as the sole means of routinely verifying sterilizer efficacy or of qualifying sterilizer performance after installation, repair, or relocation. (ANSI/AAMI ST79 Section 10.5.3.2) Although the performance of Class 5 integrating CIs has been correlated to the performance of BIs, these sterilization monitoring devices do not contain spores and thus do not directly measure the lethality of a sterilization cycle; however, they provide additional information about the attainment of critical parameters of the sterilization cycle. Neither CI can be used to replace BIs ANSI/AAMI ST79 :2010 Section 10.5.3.2 36 6

Chemical Indicator Placement Wrapped fabric packs Wrapped instrument sets Place CI in geometric center, not on the top Chemical Indicator Placement Rigid container Place two CIs inside rigid containers Place one in each of two opposite corners AORN Packaging Systems Recommendation IX 5. AORN Packaging Systems Recommendation IX 5. 37 38 Chemical Indicator Placement Chemical Indicator Placement Multi-layer rigid container Place two CIs in each level of multi-level rigid container Place one in each of two opposite corners on each level Multi-level container Supplied by the manufacturer, holes in tray, has to be wrapped Place a CI in center of each level For all these trays ask the medical device manufacturer where the greatest challenge is AORN Packaging Systems Recommendation IX 5. 39 AORN Packaging Systems Recommendation IX 5. 40 Routine Load Release Nonimplants 41 Physical monitors External process indicator (Class 1) on every package Internal chemical indicator (CI) (Class 3, 4, 5 or 6) inside every package in areas considered greatest challenge to air removal and steam penetration Optional monitoring of load with a process challenge device (PCD) containing a Biological indicator (BI) BI and a Class 5 CI Class 5 CI Class 6 CI Evaluation of all data by an experienced, knowledgeable person Do not distribute load if any data suggests a sterilization process failure ANSI/AAMI ST79:2010 Section 10.6.2, AORN Sterilization in Perioperative Practice Setting Recommendation XVI 42 AORN & AAMI ST79 Section 10.5.2.2.2 Pack control Internal chemical indicator The contents of a package with a non-responding chemical indicator should not be used Quarantine remainder of load until BI results are known If no BI, decide on recall based on physical monitors and other CI results 7

Routine Load Release Implants Physical monitors External process indicator (Class 1) on every package Internal chemical indicator (CI) (Class 3, 4, 5 or 6) inside every package in areas considered greatest challenge to air removal and steam penetration A PCD containing a BI and a Class 5 integrating indicator and quarantine load until BI results are available Evaluation of all data by an experienced, knowledgeable person Do not distribute load if any data suggests a sterilization process failure Routine Load Release Implant Loads Biological monitoring provides the only direct measure of the lethality of a sterilization cycle. Class 5 integrating indicator used to release implant in emergency situations (cannot use a Class 6 emulating indicator for early release) Emergency situations should be defined 43 ANSI/AAMI ST79:2010 Section 10.6.3, AORN Sterilization in Perioperative Practice Setting Recommendation XVI 44 ANSI/AAMI ST79:2010 Sections 10.5.3.2, 10.6.3 Early Release Implant Loads If documented medical exceptions dictate release of implant before BI result Use implant log and an exception form Critical that this documentation be fully traceable to the patient Early Release Implant Loads Exception Form for Premature Release of Implantable Device/Tray Name of implant Name of patient Name of surgeon Reason for premature release What could have prevented the premature release 45 ANSI/AAMI ST79:2010 Section 10.6.3, Annex L 46 ANSI/AAMI ST79:2010 Section 10.6.3, Annex L Flash Sterilization AORN Documentation Log or data base to trace sterilized items used on patients should include: Information on each load Item(s) processed Patient receiving the item(s) Cycle parameters used (e.g., temperature, duration of cycle) Day and time cycle is run Operator information Reason for flash sterilization Sterilizer Qualification Testing and Product Testing Sterilizer qualification testing Use a BI PCD which may contain a CI Product testing Place BIs and CIs within master product of identified families of products 47 AORN Sterilization in Perioperative Practice Setting Recommendation IV.i.1 48 ANSI/AAMI ST79:2010 Section 10.4, Table 6 8

Sterilization Process Failures Figure 12 Decision tree for conducting investigations of steam sterilization process failures Actions to take when biological indicators, chemical indicators or physical monitors indicate failure Tool: Figure 12 Decision tree for conducting investigations of steam sterilization process failures 49 ANSI/AAMI ST79:2010 Section 10.7.5, Figure 12 50 Reprinted from ANSI/AAMI ST79:2010 with permission of Association for the Advancement of Medical Instrumentation, Inc. (C) 2010 AAMI www.aami.org. All rights reserved. Further reproduction or distribution prohibited. When To Do a Recall Sterilization process failure (BI, CI, or Physical Monitor) Quarantine load, remove sterilizer from service, investigate cause of failure If cause of failure immediately identified (usually operator error such as using incorrect sterilization cycle) and confined to one load or one item within the load (internal CI) No recall, correct the cause and reprocess load If cause of failure not identified Quarantine load, recall all items processed since last negative BI (not last passed CI PCD) Determine cause of failure If minor repair-no sterilizer qualification testing If major repair-sterilizer qualification testing Table 8 Checklist for identifying reasons for steam sterilization process failures Operator errors (85%)* Incorrect use and interpretation of monitoring tools Selection of incorrect cycle for load contents Use of inappropriate packaging materials or packaging technique Incorrect loading of sterilizer 51 ANSI/AAMI ST79:2010 Section 10.7.5, Figure 12 Sterilizer Qualification Testing is Section 10.8 52 AAMI ST79:2006 A1:2008 A2:2009 10.7.5.1 Table 8 *Personal Communications Charles Hancock, Charles Hancock and Associates Table 8 Checklist for identifying reasons for steam sterilization process failures Operator errors (85%)* Incorrect use of CI PCD Incorrect selection of CI PCD for load Incorrect placement of CI PCD in load Misinterpretation of CI result Incorrect use of internal CI Incorrect selection of internal CI for the load Misinterpretation of internal CI results Incorrect documentation of results Incorrect storage of CIs Use of defective CI (expired, faded) 53 AAMI ST79:2010 Section 10.7.5.1, Table 8 *Personal Communications Charles Hancock, Charles Hancock and Associates Table 8 Checklist for identifying reasons for steam sterilization process failures Sterilizer (10%) or Utility Malfunctions (5%) Poor steam quality or quantity Incomplete air removal Inadequate cycle temperature Insufficient time at temperature 54 AAMI ST79:2010 Section 10.7.5, Table 8 *Personal Communications Charles Hancock, Charles Hancock and Associates 9

References Any Questions or Comments? Association of perioperative Registered Nurses (AORN) Perioperative Standards and Recommended Practices (2011) Recommended Practices for Sterilization in Perioperative Practice Setting Recommended Practices for Selection and Use of Packaging Systems for Sterilization 55 56 How to Purchase AORN Standards for Your Reference Library AORN Standards can be purchased through AORN using the following options: Internet: www.aorn.org/bookstore/ordering.htm Call: 1-800-755-2676 x 1 or 303-755-6304 x 1 (Monday-Friday, 8AM to 4:30PM mountain standard time) Fax: 303-750-3212 By mail: AORN, Inc., Customer Service/Book Orders, 2170 South Parker Road, Suite 300, Denver, CO 80231-5711, USA References Association for the Advancement of Medical Instrumentation (AAMI) Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79:2010 & A1:2010 (Consolidated Text) Sterilization of health care products-chemical indicators-part 1: general requirements. ANSI/AAMI/ISO 11140-1, 2005 57 58 How to Purchase AAMI Standards for Your Reference Library AAMI documents can be purchased through AAMI by credit card using the following four options: Internet: http://marketplace.aami.org Call: 1-877-249-8226 Fax: 301-206-9789 Mail: AAMI Publications, P.O. Box 0211, Annapolis Junction, MD 20701-0211 A free PDF of future amendment(s) may be downloaded by visiting http://www.aami.org/publications/standards/st79.html, which also includes information on how to update your copy of ST79. Print and save to your hard drive. Thank you! Register at www.3m.com/atteststerileu/webmeetings Next 3M Attest Sterile U Web Meeting: February 17, 2011 59 60 10